Randomized Single-Dose Three-Way Crossover Study of Pharmacokinetics of 4 mg Nicotine Pouch vs 4 mg Nicotine Lozenge in Healthy Adult Smokers

The primary objective of this three-way crossover trial is to evaluate the pharmacokinetics of a 4 mg nicotine pouch in comparison to a 4 mg nicotine lozenge in healthy adults with nicotine use. Establishing the comparative pharmacokinetic profiles is clinically relevant for understanding the absorption and systemic exposure of nicotine via different delivery systems.

The trial enrolled adult healthy volunteers of both sexes; however, the sponsor did not provide the total number of participants, specific age range, or detailed selection methodology. Individuals with Nicotine use were noted within the medical profile of the population. No additional lifestyle criteria such as diet, physical activity, or other habits were disclosed, and specific inclusion or exclusion criteria were not reported.

The study is a phase 2, open‑label, randomized single‑dose, three‑way crossover trial evaluating the pharmacokinetics of a 4 mg nicotine pouch compared with a 4 mg Nicorette® lozenge in healthy adult volunteers who have nicotine use. Screening occurs during an initial visit to confirm eligibility, followed by three dosing periods separated by washout intervals; each period includes a pre‑dose baseline assessment, drug administration, and a series of blood sampling time points to characterize drug exposure. Participants remain in the clinic for the duration of each dosing session and return for scheduled follow‑up assessments to monitor safety and collect additional pharmacokinetic samples. The end‑of‑study visit finalizes data collection and provides a safety evaluation. Overall involvement for each participant spans approximately 4–6 weeks, encompassing screening, the three treatment periods, washouts, and the final visit. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, or fails to comply with protocol requirements.

Efficacy will be assessed in accordance with the study protocol for this Nicotine use investigation. The trial is a phase 2 study, and efficacy evaluations are scheduled at predefined visits throughout the treatment period, with data collection and analysis performed as described in the protocol.